1. Lauren Madosky
Tel: (856) 761-0900 ext 117
Email: Lauren@scientificsearch.com
Fax: (856) 761-0910
Manager, Quality Assurance-San Jose, CA
PURPOSE/SUMMARY
This position is responsible for ensuring that the Quality System remains in conformance with FDA and
ISO13485 requirements, and for managing the Quality Assurance department to achieve key quality and
delivery performance metrics. The QA manager will directly support the operations, ensuring the quality
of repair operations throughout the organization. The QA Manager will serve as a key contact with
vendors, and serve as a Lead Auditor on the internal and supplier audit teams
RESPONSIBILITIES
: Manage day to day operations of Quality Assurance department. Maintain organizational structure and
align resources to achieve quality and delivery goals while improving quality wherever necessary.
Maintain and/or enhance quality system activities to ensure conformance to regulatory requirements.
: Analyze quality system data, including non-conformance reports, production test results, and other
data sources for the identification of negative quality trends. Disseminate analysis of quality data to
facilitate product quality and/or process improvements and ensure effective Corrective and Preventive
action activities where needed.
: Ensure robust and effective supplier quality program by actively participating in supplier assessments
and audits. The QA Manager is responsible for ensuring that all supplier files are kept current and in
good order.
: Develop staff to achieve service excellence in Quality Assurance personnel, and assist in training
personnel in matters relating to product quality, procedures and standards.
: Manage project activities as needed to ensure organization objectives
: Maintain a leadership role with other departments as part of Cross Functional Teams, NPI / NRI and
other areas concerning Quality Assurance.
: Perform all other essential duties as directed.
: Manage both exempt and non-exempt personnel, including QA Technicians, Associate, and Quality
Engineers to achieve department goals.
: Manage various inspections and audits, and other QA department activities.

2. EDUCATION AND/OR EXPERIENCE
: Bachelor's degree in Quality Assurance, Engineering, or Production Management, or Bachelor's degree
in another discipline with equivalent Quality Assurance knowledge required.
: At least 5 years experience in Quality Assurance.
: Minimum 3 years of medical device experience required.
: Minimum of 2 years management experience.
: CQE/CQA/CQM/RAC Certification preferred
Please email your resume to Lauren@scientificsearch.com for consideration and more details. Feel free
to send me an invite to connect. Complete job descriptions are posted on my profile. All of our openings
are listed on our website at www.scientificsearch.com. You can email me about any of the openings.